Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
1 other identifier
interventional
154
1 country
1
Brief Summary
To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 22, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedJune 27, 2018
June 1, 2018
12 months
October 22, 2017
June 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative
Patients will be followed up for three months. 3 months after the surgery, all patients will be asked to complete the Female Sexual Function Index (FSFI) questionnaire alone in a hospital room. The FSFI includes a total of 19-item validated questionnaire which was used for the evaluation of sexual desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual intercourse. Scores range from 2 to 36, higher scores indicate better sexual function. Sexual dysfunction is described as having a total FSFI score of 26.55 or less.
3 months
Secondary Outcomes (1)
operation time
during procedure
Study Arms (2)
Marsupialization
OTHERBartholin gland marsupialization will be done to all patients with Bartholin abscess.
Excision
OTHERBartholin gland excision will be done to all patients with Bartholin abscess.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-40, Bartholin cyst/abscess
You may not qualify if:
- patients with systemical diseases, patients with recurrent Bartholin abscess
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kanuni SSTRH
Istanbul, Turkey (Türkiye)
Related Publications (1)
Ozdegirmenci O, Kayikcioglu F, Haberal A. Prospective Randomized Study of Marsupialization versus Silver Nitrate Application in the Management of Bartholin Gland Cysts and Abscesses. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):149-52. doi: 10.1016/j.jmig.2008.10.006.
PMID: 19598336BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berna Aslan Çein
KSSTRH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician,ObGyn
Study Record Dates
First Submitted
October 22, 2017
First Posted
November 1, 2017
Study Start
January 1, 2017
Primary Completion
December 15, 2017
Study Completion
May 1, 2018
Last Updated
June 27, 2018
Record last verified: 2018-06